{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T03:26:16Z","timestamp":1773977176005,"version":"3.50.1"},"reference-count":25,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T00:00:00Z","timestamp":1759104000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Digit. Health"],"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>A study participant's informed consent, based on study information and expressed using a consent form (CF), is the ethical and legal basis for research with humans. Timely automatic access to a participant\u2019s consent status in different systems is crucial for knowing which medical data, images, and biological samples can be collected for research. To support time-critical (pandemic) research, this article evaluates a fully electronic consent management system and a consent collection process using a tablet PC in comparison to traditional paper-and-pencil-based approaches and assesses their impact on patient recruitment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>The evaluation is based on a COVID-19 study [the <jats:italic>Sektoren\u00fcbergreifende Plattform<\/jats:italic> (S\u00dcP) study; 2,753 study participants] that offered both paper-and-pencil- and tablet-based consent collection approaches and focused on the following: (a) initial CF validity and its impact on patient recruitment, (b) time-to-initial availability of structured consent information for other systems, (c) time-to-research based on completed quality assurance of CFs, and (d) feedback on both approaches from study staff and participants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The initial CF validity increased significantly from 67.38% for paper-and-pencil-based CFs to 99.46% for tablet-based CFs. This quality increase also reduced the number of invalid CFs or CFs requiring corrections, which can lead to study exclusion and, consequently, lower recruitment rates and lost research data. The time lag between recruitment and the availability of data decreased significantly when using tablet-based CFs, supporting time-critical research while protecting participants\u2019 privacy. Overall, the participants\u2019 and study staff's feedback on tablet-based CF collection was positive and highlighted the benefits of tablet-based CF collection in reducing the documentational burden on study staff and enabling participants to adjust the CF\u2019s appearance, for example, by choosing a bigger font size.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Although tablet-based CF collection has measurable positive effects, especially on patient recruitment rates due to an increase in initially valid CFs, the majority of the National Pandemic Cohort Network (German: <jats:italic>Nationales Pandemie Kohorten Netz<\/jats:italic>, NAPKON) study sites still solely use paper-and-pencil-based processes. Since the feedback from study staff and participants was mainly positive, other barriers beyond technical availability and workflows likely exist and need to be evaluated in further settings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Fully electronic informed consent collection is the \u201cbest practice\u201d approach to ensure valid CFs and increase initial patient inclusion rates in studies. Due to the additional benefits, including shorter time-to-research, electronic consent form collection should be integrated into pandemic response schemes and other time-critical research.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fdgth.2025.1489176","type":"journal-article","created":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T12:16:42Z","timestamp":1759148202000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["The benefits of fully electronic consent management and consent collection via a tablet PC in supporting time-critical pandemic research\u2014an example from a NAPKON COVID-19 project"],"prefix":"10.3389","volume":"7","author":[{"given":"Dana","family":"Stahl","sequence":"first","affiliation":[]},{"given":"Henriette","family":"Rau","sequence":"additional","affiliation":[]},{"given":"Arne","family":"Blumentritt","sequence":"additional","affiliation":[]},{"given":"Lizon","family":"Fiedler-Lacombe","sequence":"additional","affiliation":[]},{"given":"Ekaterina","family":"Heim","sequence":"additional","affiliation":[]},{"given":"Heike","family":"Valentin","sequence":"additional","affiliation":[]},{"given":"Martin","family":"Bialke","sequence":"additional","affiliation":[]},{"given":"Monika","family":"Kraus","sequence":"additional","affiliation":[]},{"given":"Wolfgang","family":"Hoffmann","sequence":"additional","affiliation":[]}],"member":"1965","published-online":{"date-parts":[[2025,9,29]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1007\/s10916-006-9030-3","article-title":"Consent mechanisms for electronic health record systems: a simple yet unresolved issue","volume":"31","author":"Win","year":"2007","journal-title":"J Med Syst"},{"key":"B2","volume-title":"Guideline for Good Clinical Practice E6(R2)","year":"2018"},{"key":"B3","article-title":"The process of obtaining informed consent.","year":""},{"key":"B4","article-title":"Templates for informed consent forms","year":""},{"key":"B5","doi-asserted-by":"crossref","DOI":"10.32745\/9783954666034","volume-title":"Data Privacy in European Medical Research: A Contemporary Legal Opinion","author":"Dierks","year":"2021"},{"key":"B6","article-title":"Regulation (EU) 2016\/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95\/46\/EC (General Data Protection Regulation)","year":"2016"},{"key":"B7","article-title":"European Convention on Human Rights, as Amended by Protocols Nos. 11, 14 and 15, Supplemented by Protocols Nos. 1, 4, 6, 7, 12, 13 and 16","year":"2021"},{"key":"B8","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects","volume":"310","year":"2013","journal-title":"JAMA"},{"key":"B9","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1007\/s00117-019-00629-6","article-title":"[Analysis of documented informed consent forms for computed tomography: completeness and data quality in four clinics]","volume":"60","author":"Vogele","year":"2020","journal-title":"Radiologe"},{"key":"B10","article-title":"Electronic consent management: landscape assessment, challenges, and technology (2014)","year":""},{"key":"B11","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1007\/s10654-022-00896-z","article-title":"The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics","volume":"37","author":"Schons","year":"2022","journal-title":"Eur J Epidemiol"},{"key":"B12","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1186\/s12967-020-02457-y","article-title":"The generic Informed Consent Service gICS\u00ae: implementation and benefits of a modular consent software tool to master the challenge of electronic consent management in research","volume":"18","author":"Rau","year":"2020","journal-title":"J Transl Med"},{"key":"B13","doi-asserted-by":"publisher","first-page":"335","DOI":"10.1186\/s12911-022-02081-4","article-title":"A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine","volume":"22","author":"Bialke","year":"2022","journal-title":"BMC Med Inform Decis Mak"},{"key":"B14","doi-asserted-by":"publisher","first-page":"364","DOI":"10.3414\/ME14-01-0133","article-title":"MOSAIC\u2014a modular approach to data management in epidemiological studies","volume":"54","author":"Bialke","year":"2015","journal-title":"Methods Inf Med"},{"key":"B15","article-title":"Trusted Third Party of the University Medicine Greifswald. gICS\u00ae","year":"2025"},{"key":"B16","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1186\/s12967-015-0545-6","article-title":"A workflow-driven approach to integrate generic software modules in a trusted third party","volume":"13","author":"Bialke","year":"2015","journal-title":"J Transl Med"},{"key":"B17","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1186\/s12967-020-02257-4","article-title":"Assessment of scalability and performance of the record linkage tool E-PIX\u00ae in managing multi-million patients in research projects at a large university hospital in Germany","volume":"18","author":"Hampf","year":"2020","journal-title":"J Transl Med"},{"key":"B18","doi-asserted-by":"crossref","DOI":"10.32745\/9783954663743","volume-title":"Datenqualit\u00e4t in der Medizinischen Forschung: Leitlinie zum Adaptiven Management von Datenqualit\u00e4t in Kohortenstudien und Registern","author":"Nonnemacher","year":"2014"},{"key":"B19","doi-asserted-by":"publisher","first-page":"e10","DOI":"10.1055\/s-0042-1760249","article-title":"We know what you agreed to, don't we?\u2014Evaluating the quality of paper-based consents forms and their digitalized equivalent using the example of the Baltic Fracture Competence Centre project","volume":"62","author":"Rau","year":"2023","journal-title":"Methods Inf Med"},{"key":"B20","article-title":"WHO Director-General\u2019s opening remarks at the media briefing\u20145 May 2023","year":""},{"key":"B21","article-title":"E-ConsentPro software (2025)","year":""},{"key":"B22","doi-asserted-by":"publisher","first-page":"T64","DOI":"10.1016\/j.farma.2023.01.002","article-title":"[Translated article] Design and validation of two instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products","volume":"47","author":"Jaramillo Velez","year":"2023","journal-title":"Farm Hosp"},{"key":"B23","doi-asserted-by":"publisher","first-page":"114333","DOI":"10.1016\/j.psychres.2021.114333","article-title":"An exploration of research participation by persons of minority and underrepresented groups: barriers to diversification in recruitment, minority investigator participation, and solutions","volume":"308","author":"Crittenden-Ward","year":"2022","journal-title":"Psychiatry Res"},{"key":"B24","doi-asserted-by":"publisher","first-page":"105545","DOI":"10.1016\/j.ijmedinf.2024.105545","article-title":"#Consented\u2014a semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research","volume":"190","author":"Bialke","year":"2024","journal-title":"Int J Med Inform"},{"key":"B25","article-title":"Consent management. FHIR implementation guide (version: 1.0.2)","year":""}],"container-title":["Frontiers in Digital Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2025.1489176\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T12:16:43Z","timestamp":1759148203000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2025.1489176\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,29]]},"references-count":25,"alternative-id":["10.3389\/fdgth.2025.1489176"],"URL":"https:\/\/doi.org\/10.3389\/fdgth.2025.1489176","relation":{},"ISSN":["2673-253X"],"issn-type":[{"value":"2673-253X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,29]]},"article-number":"1489176"}}